Drug store Excellence Audit Checklist

Transcription

1 Areas of Concern Serial Number Audited Issues References Compliance with Legal & Professional Obligations 1 The facility is certified to GSP and GDP from a reputable certification body. 2 The store must have the capacity for storage of material and handling of orders. As a minimum requirement there has to be a section for the storage of valid products, a section for the preparation of orders, a temporary receiving area, a quarantine area and a receiving and dispatch bays (preferable to have two separate bays). Layout of the Storage Area 3 Accessibility to store area is limited for authorized staff only with an electronic punching. 4 If using pallets, stack cartons on pallets shall be: a- At least 10 cm (4 inches) off the floor. b- At least 30 cm (1 foot) away from the walls and other stacks. c- No more than 2.5 m (8 feet) high. Guidelines for the storage of Essential Medicines and other Health Commodities 1 JDRE/HSC/PA/2012/1.1

2 5 If using shelves and racks; should be arranged in lines with a passageway not less than 90 cm wide, and 15 cm away from the walls of the store If there is a need to access shelves and racks from two sides then they shall be placed 90 cm from the walls of the storeroom, Guidelines for the storage of Essential Medicines and other Health Commodities (WHO, UNICEF) 6 There is an inventory management system to ensure uninterrupted supply and/or availability of medicines (electronic reordering, alert on minimum stock etc.) HCRM 7 Medical products Receiving & Dispatching Area 7 Receiving and dispatch bays should protect products from the weather thus maintain product integrity. 8 Quarantine area shall be well isolated, separated and clearly labeled. It shall provide for the proper segregation of rejected, recalled products, expired products and damaged products. Quarantine Area 9 Quarantine area is restricted only for authorized personnel. 10 Forklifts and pallet lifters If the store uses forklifts or pallet lifters, it shall: a- Ensure the lifter has room to load and unload products. b- Keep an extra battery or a battery charger, if needed. Ensure the battery can last a full day. c- Guidelines for the storage of Essential Medicines and other Health Commodities (WHO, UNICEF) 2 JDRE/HSC/PA/2012/1.1

3 Ensure the lifter can reach the highest pallet rack. d- Keep a record of maintenance and servicing of the lifter in a secure, visible place. e- Maintain and post picture identification of employees who have been trained and are authorized to operate the lifter. Monitoring & Control of Storage Conditions during Storing & Transportatio n 11 Housekeeping 12 Quality Management Temperature mapping which is conducted by qualified provider shows uniformity of the temperature across the storage facility or transporting vehicle. Training should be provided for cleaning personnel in a way to ensure better understanding on the importance of the cleaning procedures followed. The facility adopts an independent double checking system in line with international guidelines. There should be a documented quality policy describing the overall intentions and policies of the establishment regarding quality, as formally expressed and authorized by upper management. GPP 3 JDRE/HSC/PA/2012/1.1

4 Documentatio n: Instructions, Written SOPs & Records Appropriate infrastructure or quality system, encompassing the organizational structure, procedures, processes and resources The facility is certified to ISO standards or any qualifying scheme from a reputable certification body. Written standardized work procedures (SOP), instructions and records that should be: 18 Available for review 19 To clearly explain work procedures., HCPDM ch5. general duties, governance and change of control, HCPDM CHAPTER VII. STAFFING AND STAFF MANAGEMENT/job description 20 To include and document all activities and procedures followed in the storage premises. Instructions for Receiving Supplied Materials or Products 21 Comprehensive records should be maintained showing all import permits, receipts and relevant invoices, including purchase orders and issues of materials and pharmaceutical products according to a specified system, e.g. by batch number, stock cards etc. 4 JDRE/HSC/PA/2012/1.1

5 22 Effective measures should be in place to ensure that rejected; defected or expired materials and pharmaceutical products cannot be used or bypassed. They should be stored separately from other materials and pharmaceutical products while awaiting their disposal either by destruction or return to the supplier. Stock Rotation & Control Products are arranged in a way that facilitates the first-to-expire, first-out (FEFO) procedure. Establish an effective system to identify and handle medicines that are due to expire; including but not limited to shelf checking. Guidelines for the storage of Essential Medicines and other Health Commodities (WHO, UNICEF) GSP, GPP 25 Periodic stock reconciliation should be performed by comparing the actual and recorded stocks. Stock Dispatch Procedures & Instructions Regular checks should be carried out for all stocks to identify and remove obsolete and outdated materials or products. Care should be taken on selling or distributing pharmaceutical products only to parties or entities that are legally licensed and entitled to acquire such products. Written proof of such entitlement must be obtained prior to the dispatch of products 5 JDRE/HSC/PA/2012/1.1

6 to any party. 28 Records of dispatch should contain enough information to enable traceability of the pharmaceutical products. Such records should facilitate the recall of a batch of a product from markets or users if necessary. The records and documents of the received and dispatched consignments should be available and kept in a way that enables its quick review on need or on the request of relevant official authorities. Complaints Handling 29 There is a documented procedure for the handling of complaints which clarify procedures to be followed for information collection, investigating facts and follow up corrective actions. A distinction should be made between complaints about a product or its packaging and those relating to distribution. Waste Management 30 The facility has a documented arrangement for managing wastes that meets the current laws and regulations., 6 JDRE/HSC/PA/2012/1.1

7 Staff Management 31 Maintain and follow a staffing plan that is updated at least on yearly basis considering the new challenges and identified need of the facility. HCPDM CHAPTER VII. STAFFING AND STAFF MANAGEMENT, GAHS 1-05 staffing plan SS/PD/PHA 32 Maintain an optimum staff to work- load ratio. The facility adopts any of the universally accepted formula (including but not limited to Full-Time-Equivalent, FTE) to assess the staff work load and operational capacity. GPP 33 Ensure there is an induction / orientation program. HCPDM CHAPTER VII. STAFFING AND STAFF MANAGEMENT, GAHS 1-08 continuing education 34 Maintain a robust staff roster system which supports the delivery of enhanced pharmaceutical services. HA-AD circular 4/2007, GAHS 1-03 department performance improvement plan (roles and responsibilities), HCPDM Chapter 8 35 Follow an internal communication policy to timely inform staff on relevant issues affecting them and/or their work environment. GAHS 1-04 SS/PD/PHAcommunication plan, HCPDM 5/ CHAPTER V. GENERAL DUTIES, GOVERNANCE AND CHANGE OF CONTROL 7 JDRE/HSC/PA/2012/1.1

8 36 Maintain and follow a performance review system to monitor, appraise and manage staff performance. GAHS 1-03 SS/PD/PHA department performance improvement plan, HCPDM 5/ CHAPTER V. GENERAL DUTIES, GOVERNANCE AND CHANGE OF CONTROL 37 Maintain a personnel file for each staff member. HCPDM 4/ CHAPTER VII. STAFFING AND STAFF MANAGEMENT, PART C. STAFF MANAGEMENT AND TRAINING 38 Follow a staff retention policy. Ensure all staff to be offered with an exit interview before terminating his contract and/or exiting from his current job (facility) GPP, ASHP, HCPDM 4/ CHAPTER VII. STAFFING AND STAFF MANAGEMENT, 39 Ensure all relevant feedback received during the exit interview to be used for quality improvement process. GPP, ASHP 40 Ensure all employees who are quitting are offered a Statement of Service and a Training Record. GPP, ASHP Ongoing Staff Training 41 Ensure all pharmacists to be adequately trained on First Aid management /BLS, ALS HCPDM chapter 7 staffing and staff management /training 8 JDRE/HSC/PA/2012/1.1

9 42 Maintain an annual training plan and training record for each staff member that documents the training needs relevant to the position held. GAHS 1-08 SS/PD/PHA continuing education, HCPDM chapter 7 staffing and staff management 43 Follow a process to ensure that concerned staff dealing with controlled medications gets clearance from the narcotic pharmacy before leaving/ resigning from the institution. GPP Maintaining safety and security 44 Maintain and follow appropriate systems for the management of occupational, environmental, health and safety risks. Environment, Health and Safety Management System for the Health Sector- Management and Administration Manual - HAAD/HSED/ST/0000/HS _EHSMS, HCPDM ch 6 environment health and safety management Information Technology 45 The facility has an IT system with required security and data backup, to further support facility operations. GPP 9 JDRE/HSC/PA/2012/1.1